MAUDE Adverse Event Report: HOLGER ULLRICH MEERA EU WITHOUT AUTO DRIVE; TABLE, OPERATING-ROOM, AC-POWERED

Model Number 720001B0 - MEERA EU WITHOUT AUTO DRIVE

Device Problem Patient Device Interaction Problem (4001)

Patient Problem Abrasion (1689)

Event Date 01/10/2022

Event Type  Injury  

Event Description

Patient got stage 2 pressure injury over sacrum and both buttocks (redness with small blisters) after long procedure (internal fixation of maxillary fracture ¿ 8 hrs).Or table used was maquet meera.Manufacturer reference # (b)(4).

Manufacturer Narrative

The complaint database was reviewed concerning similar complaints for the affected model.No similar complaints or comparable incidents were registered.The affected or table 720001b0 - meera eu without auto drive, sn (b)(4) is in clinical use for over 2 years and no complaint was registered for this device until now.Pressure marks can be caused by various influences (long duration of the surgery, positioning of the patient, high bmi, intraoperative compression of large blood vessels, intraoperative hypothermia, intraoperative low blood pressure.).We suspect that a combination of some of these unfavorable factors has been present in this case and caused the described injury.An extended duration of the surgery in a position, e.G.Supine position, lasting more than 7 hours are high risk factors for developing pressure marks.In the ifu the user is warned concerning the risks related to patient positioning as follows: "warning! risk of injury! improper patient positioning may cause health damage (e.G.Decubitus).Position the patient correctly and keep under constant observation." getinge-maquet provides product failure investigation, analysis and resolution for the device described in this report.

• Brand Name: MEERA EU WITHOUT AUTO DRIVE
• Type of Device: TABLE, OPERATING-ROOM, AC-POWERED
• Manufacturer (Section D): HOLGER ULLRICH; maquet gmbh; kehler strasse 31,; rastatt 76437 ; GM 76437
• Manufacturer (Section G): HOLGER ULLRICH; maquet gmbh; kehler strasse 31,; rastatt 76437 ; GM 76437
• Manufacturer Contact: maquet gmbh; kehler strasse 31,; rastatt 76437
• MDR Report Key: 13503726
• MDR Text Key: 285387017
• Report Number: 8010652-2022-00001
• Device Sequence Number: 1
• Product Code: FQO
• Combination Product (y/n): N
• Reporter Country Code: TC
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Foreign,Health Professional,User Facility,Company Representative
• Reporter Occupation: Other Health Care Professional
• Type of Report: Initial
• Report Date: 02/09/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 02/10/2022
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Model Number: 720001B0 - MEERA EU WITHOUT AUTO DRIVE
• Device Catalogue Number: 720001B0
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 01/11/2022
• Date Device Manufactured: 08/15/2019
• Is the Device Single Use?: No
• Type of Device Usage: Reuse
• Patient Sequence Number: 1
• Patient Outcome(s): Other
• Patient Sex: Prefer Not To Disclose